| 对比ADR监测分析《医疗器械不良事件监测和再评价管理办法(试行)》的实施障碍 |
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| 引用本文： | 郑小溪,李怡勇,陆庆生. 对比ADR监测分析《医疗器械不良事件监测和再评价管理办法(试行)》的实施障碍[J]. 中国医学装备, 2011, 8(3): 23-26 |
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| 作者姓名： | 郑小溪 李怡勇 陆庆生 |
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| 作者单位： | 广州军区武汉总医院医学工程科,湖北武汉,430070 |
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| 摘 要： | 阐明了药品与医疗器械的相关性和相似性,详细介绍我国药品不良反应监测的发展情况和成功做法,重点分析<医疗器械不良事件监测和再评价管理办法(试行)>宏观上的实施障碍及细节方面的影响因素,并提出相关改善建议,以期完善<医疗器械不良事件监测和再评价管理办法(试行)>的实施环节,确保其实施效果.
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| 关 键 词： | 药品不良反应监测 医疗器械不良事件监测 再评价 障碍 建议 |
Analysis of implementation obstruction of Medical Device Adverse Event Monitoring and Re-evaluation Management Regulations (on Trial) by contrast with ADR monitoring |
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| ZHENG Xiao-xi,LI Yi-yong,LU Qing-sheng. Analysis of implementation obstruction of Medical Device Adverse Event Monitoring and Re-evaluation Management Regulations (on Trial) by contrast with ADR monitoring[J]. China Medical Equipment, 2011, 8(3): 23-26 |
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| Authors: | ZHENG Xiao-xi LI Yi-yong LU Qing-sheng |
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| Affiliation: | ZHENG Xiao-xi,LI Yi-yong,LU Qing-sheng Department of Medical Engineering,Wuhan General Hospital,Guangzhou Command,Wuhan 430070,China. |
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| Abstract: | The paper clarifies the similarity of drugs and medical devices, specifies the development and successful practices of ADR monitoring, emphases analyze macroscopic implementation obstruction and detailed influence factors of , and then proposes improvement suggestions, so as to consummates the implementation tache of , ensur... |
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| Keywords: | Adverse drug reaction monitoring Medical devices adverse event monitoring Re-evaluation Obstruction Suggestion |
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